ABRAXANE phase III trial shows improved results

Professor John Zalcberg, chief medical officer and executive director of Cancer Medicine at the Peter MacCallum Cancer Centre in Melbourne, said the evidence strongly supported using ABRAXANE in combination with gemcitabine as a new standard of care to treat appropriate patients, many of whom were not diagnosed until the disease was metastatic.While acknowledging that this advance could not be seen as a cure for pancreatic cancer, Professor Zalcberg said the 59 percent increase in the number of patients who lived beyond 12 months was very encouraging.

"We are extremely encouraged by the results of this study involving ABRAXANE and regard this outcome as a significant breakthrough in terms of the future management of this disease," he said. "In addition to treating women with metastatic breast cancer with ABRAXANE in the appropriate setting, we look forward to its approval in Australia for treating patients with advanced pancreatic cancer."

Specialised Therapeutics Australia (STA) Chief Executive Officer Mr Carlo Montagner said the positive data paved the way for Australian patients with advanced pancreatic cancer to access more effective treatment options.He commented: "In Australia, pancreatic cancer is the fourth most common cause of death from cancer for both men and women and very few treatment options exist for this group of patients. We are extremely pleased to demonstrate that ABRAXANE is capable of prolonging survival for patients with advanced pancreatic cancer and we hope to have ABRAXANE approved by the Australian Therapeutic Goods Administration (TGA) in the latter half of 2014."

The most common grade ≥ 3 treatment-related adverse events in the study for ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia (38 percent vs. 27 percent), fatigue (17 percent vs. 7 percent), and neuropathy (17 percent vs. 1 percent). In the ABRAXANE plus gemcitabine arm, the median time to neuropathy improvement was 29 days. There was no difference in serious life threatening toxicity (4 percent in each arm).